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The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine in two different dose forms in participants who are generally healthy or with stable pre-existing health conditions.
This is a Phase II, prospective, randomized, double-blinded (investigator/site staff and participants; Sponsor open), dose-comparison, multi-center study. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by comorbidity. All eligible participants will be randomized to receive 2 doses of either High-dose or Mid-dose of MVC-COV190 in a predefined ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Experimental | High-Dose S-2P protein with CpG and Aluminum Hydroxide/0.5mL |
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| Mid Dose | Experimental | Mid-Dose S-2P protein with CpG and Aluminum Hydroxide/0.5mL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVC-COV1901 (High-Dose) | Biological | Approximately 300 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events(AEs) [Safety and Tolerability] | To evaluate the incidence of Adverse Events(AEs) of MVC-COV1901 from Visit 2 (Day 1) to Visit 6 (28 days after the second dose of study intervention) in terms of the number and percentage of participants with the occurrence of: Solicited local AEs (up to 7 days after each dose of study intervention) Solicited systemic AEs (up to 7 days after each dose of study intervention) Unsolicited AEs (up to 28 days after each dose of study intervention) AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs) | Day 1 to 28 days after the second vaccination |
| Immunogenicity of MVC-COV1901 | To evaluate the immunogenicity of High-dose MVC-COV1901, as compared to Mid-dose MVC-COV1901, in terms of neutralizing antibody titers. | Day 1 to 28 days after the second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events(AEs) [Safety and Tolerability] | To evaluate the Incidence of Adverse Events(AEs) of MVC-COV1901 over the study period in terms of the number and percentage of participants with the occurrence of: >= Grade 3 AE AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs) | Day 1 to 180 days after the second vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Szu-Min Hsieh, MD | National Taiwan University Hospital | Principal Investigator |
| Tzou-Yien Lin, MD | Chang Gang Memorial Hospital, LinKou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hualien Tzu Chi Hospital | Hualien City | Taiwan | ||||
| Shuang H Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36049700 | Derived | Waits A, Chen JY, Cheng WH, Yeh JI, Hsieh SM, Chen C, Janssen R, Lien CE, Lin TY. Safety and immunogenicity of MVC-COV1901 vaccine in older adults: Phase 2 randomized dose-comparison trial. Int J Infect Dis. 2022 Nov;124:21-26. doi: 10.1016/j.ijid.2022.08.021. Epub 2022 Aug 29. |
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| ID | Term |
|---|---|
| C000718807 | MVC-COV1901 vaccine |
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| MVC-COV1901(Mid-Dose) | Biological | Approximately 100 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region |
|
| Immunogenicity of MVC-COV1901 | The antigen-specific immunoglobulin titers and neutralizing antibody titers at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28 days after the second dose of study intervention), Visit 7 (90 days after the second dose of study intervention) and Visit 8 (180 days after the second dose of study intervention) in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers | Day 1 to 180 days after the second vaccination |
| New Taipei City |
| Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Chang Gung Medical Hospital Linkou | Taoyuan | Taiwan |